MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RUNTHROUGH NS; WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the tip of the runthrough device involved damaged while inside the balloon, during an angioplasty.The estimated blood loss was less than 250cc.The patient was in stable condition.The procedure outcome was a technical success.There was no patient injury/medical or surgical intervention required.The event occurred intra-operative.Additional information was received on 27 jun 2022: a new wire was used.Additional information was received on 19 aug 2022: the doctor thought the tip was inside of the balloon.

• Brand Name: RUNTHROUGH NS
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 15349705
• Report Number: 2243441-2022-00022
• Device Sequence Number: 14832273
• Product Code: DQX
• UDI-Device Identifier: 04987350721006
• UDI-Public: 04987350721006
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2022
• Report Date (Section F): 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 25-3013
• Device Lot Number: 210309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/10/2022
• Device Age: 15 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/02/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Hispanic
• Date Report Sent to FDA: 09/02/2022